Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Despite the positive outcomes of invasive weight loss procedures, such as gastric bypass surgery, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP-BAND AP® (Allergan, Inc., Irvine, Calif.) gastric band. Generally, gastric bands are placed about the fundus, or cardia, or esophageal junction, of a patient's upper stomach forming a stoma that restricts the food's passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, the food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. Unlike gastric bypass procedures, gastric band apparatus are reversible and require no permanent modification to the gastrointestinal tract. An example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference.
Existing gastric bands periodically require adjustments to maintain an effective constriction about the stomach, to account for changes in the stomach tissue, reduction of fat or other factors causing movement and/or size change of the stomach. Some attempts have been made to allow for such adjustment of gastric bands. For example, hydraulic gastric bands utilize a fluid such as saline to fill an inflatable portion of the gastric band using a subcutaneous injection access port. Adjustments to the amount of inflation may be made by injecting or extracting the fluid through the patient's skin into or out of the injection access port, which then directs the fluid into or out of the inflatable portion of the gastric band.
Current access ports are typically configured to include a flat-surfaced septum, a rigid housing, and a substantially flat base. The housing forms a rim around the septum to expose a circular surface area of the septum. One of the main features of the access port is the port attachment and/or integration with the patient's body. The port fixation must be able to handle the load associated with locating the injection site (e.g., via palpation). Moreover, when the needle punctures the septum for the adjustment of the fluid levels within the gastric band, the port fixation must hold under the needle insertion and removal forces. While the access port may be fixated to the body of the patient in one of many ways, among the most conventional is suturing the access port to the body tissue via suture holes located on the access port, for example, as illustrated in FIG. 1A. However, solely suturing the access port to the patient's body might not be optimal in some patients. Alternatively and/or in addition, an implantable mesh may be used. The mesh is usually attached or sutured onto the access port, allowing the body tissues to ingrow around the mesh geometry.
Some attempts have been made to improve the fixation of the access port to the body of the patient. For example, Tallarida, et al., U.S. Pat. No. 5,906,596 describes an access port with an attached mesh sandwiched between the base and top as shown in FIG. 1B, but does not describe any usage of a mesh rivet.
Williams, U.S. Pat. Pub. No. 20110035008 describes anchoring a mesh to bone as shown in FIG. 1C, but does not describe the use of a mesh rivet for attaching a mesh to an access port.
Buevich, et al., U.S. Pat. Pub. No. 20080132922 describes a fixation method using mesh to a medical device as shown in FIG. 1D. However, Buevich fails to mention the use of mesh rivets.
Green, et al., U.S. Pat. Pub. No. 20020117534 describes mesh and tissue attachments as shown in FIG. 1E. However, Green does not describe any details related to the attachment of the mesh to medical devices.
Chen, et al., U.S. Pat. Pub. No. 20050131383 describes the use of mesh with respect to injection sites as shown in FIG. 1F, but does not describe any methods of attaching the mesh.
Denoziere, et al., U.S. Pat. No. 7,879,100 describes the attachment of mesh to medical devices by molding the mesh into the medical device as shown in FIG. 1G. However, Denoziere attaches the mesh to the medical device without the use of rivets.
The access ports currently on the market and those described above suffer from known drawbacks, including cost, complexity, and effectiveness. Accordingly, it is desirable to develop a gastric banding system, and an implantable access port designed to remedy the deficiencies of access ports currently on the market.